SemBioSys initiates toxicology study for safflower-produced insulin

    Initiation of study puts company on track for Phase I/II trial

    TSX symbol: SBS

    CALGARY, March 26 /CNW/ - SemBioSys Genetics Inc. (TSX: SBS), a
biotechnology company developing a portfolio of therapeutic proteins for
metabolic and cardiovascular diseases, today announced that it has initiated a
toxicology study in animals to demonstrate the safety and comparability of its
safflower-produced insulin to pharmaceutical grade human insulin. This study
is a final key step in the Company's preparations to submit an Investigational
New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in
the third quarter in order to initiate a Phase I/II human clinical trial this
year. The 28-day repeat dose study in monkeys and rats is the only toxicology
study required before submission of the IND application to the FDA. The study
is also a required component for the abbreviated 505(b)(2) application process
that SemBioSys is eligible to follow, based on the well-characterized nature
of insulin. The study aims to establish that the toxicology profile of insulin
produced from SemBioSys' plant system is appropriate to begin human trials.
    "Insulin is currently one of the largest volume recombinant
biopharmaceutical products on the market and demand is projected to increase
dramatically in the coming years. The scalability of our safflower-produced
insulin has the potential to provide a cost-effective source of insulin to
meet this growing demand," said Andrew Baum, President and CEO of SemBioSys.
"In order to start the toxicology study we had to demonstrate that our
safflower-produced insulin is chemically, physically and structurally
equivalent to human insulin using a broad array of assays. The toxicology
study is an important milestone for our insulin program and demonstrates that
we are on track to begin human clinical trials in the second half of 2008."
    SemBioSys has already established that safflower-produced insulin is
physically, structurally and physiologically indistinguishable from
pharmaceutical-grade human recombinant insulin in laboratory testing. In a
standard quantitative blood sugar assay performed in rabbits (insulin
tolerance test), SemBioSys has demonstrated the pharmacodynamic equivalence of
safflower-produced insulin to pharmaceutical-grade insulin. Thus the
completion of this toxicology study fulfills the pre-requisite for filing the
    The world market for insulin is US$7.1 billion today and the demand for
insulin is projected to increase due to two factors. Demographic and dietary
choices in the western world are causing an increase in the incidence of
diabetes. At the same time, countries in the rest of the world, that are
currently underserved in the insulin market, are demanding greater access to
insulin at an affordable price. By 2012, independent estimates predict a
US$15 billion insulin market. SemBioSys' plant-made insulin will offer
dramatic capital and operating cost reductions with the potential to enter the
market as a low-cost source of insulin to meet this exploding demand.

    About SemBioSys Genetics Inc. (

    Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company
developing protein-based pharmaceuticals for metabolic and cardiovascular
diseases. The Company's lead pharmaceutical candidates, produced in the plant
host safflower, are recombinant human insulin to serve the rapidly expanding
global diabetes market and Apo AI, a next generation cardiovascular drug. In
addition to its pharmaceutical products, SemBioSys is developing a series of
non-pharmaceutical products addressing human topical, nutritional oils and
agricultural biotechnology markets.

    This press release contains certain forward-looking statements,
including, without limitation, statements containing the words "believe",
"may", "plan", "will", "estimate", "continue", "anticipate", "intend",
"expect" and other similar expressions which constitute "forward-looking
information" within the meaning of applicable Canadian securities laws.
Forward-looking statements reflect the Company's current expectation and
assumptions, and are subject to a number of risks and uncertainties that could
cause actual results to differ materially from those anticipated. These
forward-looking statements involve risks and uncertainties including, but not
limited to, changing market conditions, the successful and timely completion
of clinical studies, the establishment of corporate alliances, the impact of
competitive products and pricing, new product development, uncertainties
related to the regulatory approval process and other risks detailed from
time-to-time in the Company's ongoing filings with the Canadian securities
regulatory authorities which filings can be found at Given
these risks and uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements. The Company undertakes no
obligation to publicly update or revise any forward-looking statements either
as a result of new information, future events or otherwise, except as required
by applicable Canadian securities laws.

For further information:

For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
President and Chief Executive Officer, Phone: (403) 717-8767, Fax: (403)
250-3886, E-mail:, Internet:; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail:

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